01 1Hetero Drugs
01 1SOTORASIB (FORM-III)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-04-20
Pay. Date : 2025-03-07
DMF Number : 41270
Submission : 2025-03-03
Status : Active
Type : II
20
Hetero Labs Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is SOTORASIB (FORM-III), with a corresponding US DMF Number 41270.
Remarkably, this DMF maintains an Active status since its submission on March 03, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 20, 2025, and payment made on March 07, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
